🍔 Food 💊 Drugs 🏥 Medical Devices
Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015; NDC 0363-9947-35. Class II

Reason: Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.

Aurobindo Pharma USA Inc. 20230522 Completed
Distributed: The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.
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Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99 Class II

Reason: Lack of Assurance of Sterility

Sagent Pharmaceuticals Inc 20230519 Ongoing
Distributed: Nationwide USA
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Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10 Class II

Reason: Lack of Assurance of Sterility

Sagent Pharmaceuticals Inc 20230519 Ongoing
Distributed: Nationwide USA
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Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10 Class II

Reason: Lack of Assurance of Sterility

Sagent Pharmaceuticals Inc 20230519 Ongoing
Distributed: Nationwide USA
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buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86 Class II

Reason: Failed Dissolution Specifications; during stability testing

SUN PHARMACEUTICAL INDUSTRIES INC 20230509 Terminated
Distributed: Nationwide in the U.S.A
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FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Park, Pittsburgh, PA 15238, Class II

Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

Alpha Aromatics 20230516 Terminated
Distributed: Product was distributed to one account in NC.
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Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories Class II

Reason: CGMP Deviations: recalling drug products following an FDA inspection.

Amerisource Health Services LLC 20230317 Terminated
Distributed: Nationwide USA
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Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories Class II

Reason: CGMP Deviations: recalling drug products following an FDA inspection.

Amerisource Health Services LLC 20230317 Terminated
Distributed: Nationwide USA
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Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories Class II

Reason: CGMP Deviations: recalling drug products following an FDA inspection.

Amerisource Health Services LLC 20230317 Terminated
Distributed: Nationwide USA
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Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit, Ahmedabad 382213, India, Amneal Pharamceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1574-01. Class III

Reason: Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.

Amneal Pharmaceuticals of New York, LLC 20230508 Terminated
Distributed: Nationwide in the USA and PR
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